Single Dose Escalation Study of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease

July 24, 2009 updated by: Pfizer

An Open Label, Single Dose Escalation Study Of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease

The purpose of this study is to determine whether single doses of PF-04360365 is safe and well tolerated in patients with Alzheimer's Disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91206
        • Pfizer Investigational Site
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Pfizer Investigational Site
      • Oakhurst, New Jersey, United States, 07755
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female (of non-child bearing potential) subjects ages ≥50 years of age.
  • Diagnosis of probable AD (of mild to moderate severity), consistent with criteria from both: NINCDS-Alzheimer's Disease and Related Disorders Association (ADRDA) and DSM-IV-TR.
  • MMSE score of 16-26 inclusive.
  • Rosen-Modified Hachinski Ischemia Score ≤4.
  • On a stable dose of background cholinesterase inhibitors or memantine for at least 60 days prior to dosing.

Exclusion Criteria:

  • Diagnosis or history of other dementia or neurodegenerative disorders.
  • Diagnosis or history of clinically significant cerebrovascular disease.
  • Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes.
  • History of allergic or anaphylactic reactions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PF-04360365 1 mg/kg
Biological: PF-04360365 1 mg/kg
PF-04360365 1 mg/kg infused as a single dose
Experimental: PF-04360365 3 mg/kg
Biological: PF-04360365 3 mg/kg
PF-04360365 3 mg/kg infused as a single dose
Experimental: PF-04360365 5 mg/kg
Biological: PF-04360365 5 mg/kg
PF-04360365 5 mg/kg infused as a single dose
Experimental: PF-04360365 10 mg/kg
Biological: PF-04360365 10 mg/kg
PF-04360365 10 mg/kg infused as a single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To examine the safety and tolerability of a single dose of PF-04360365 in subjects with mild-to-moderate AD.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To characterize the pharmacokinetic profile of PF-04360365 following administration of an IV infusion in subjects with mild-to-moderate AD.
Time Frame: 6 months
6 months
To evaluate the relationship of PF-04360365 plasma exposure and Aβ plasma exposure.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

August 11, 2008

First Submitted That Met QC Criteria

August 11, 2008

First Posted (Estimate)

August 13, 2008

Study Record Updates

Last Update Posted (Estimate)

July 28, 2009

Last Update Submitted That Met QC Criteria

July 24, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A9951008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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